Injections: Drugs S-Z Policy - Medi-Cal

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inject drug s-z1Injections: Drugs S-Z PolicyPage updated: September 2020This section outlines policy related to billing for injection services, listed in alphabetical orderby generic drug name or drug type. For general billing policy information regardinginjections services, refer to the Injections: An Overview section in this manual. Additionalpolicy information for injection services can be found in the following sections of this manual:Injections: Drugs A-D PolicyInjections: Drugs E-H PolicyInjections: Drugs I-M PolicyInjections: Drugs N-R PolicyInjections: HydrationImmunizationsSargramostimSargramostim is a recombinant human granulocyte-macrophage colony stimulating factor(rhu GM-CSF) produced by recombinant DNA technology in a yeast expression system.GM-CSF is a hematopoietic growth factor which induces partially committed progenitor cellsto divide and differentiate in the granulocyte-macrophage pathways including neutrophils,monocytes/macrophages and myeloid-derived dendritic cells.IndicationsSargramostim is indicated for use: Following induction chemotherapy in acute myelogenous leukemia In mobilizing and following transplantation of autologous peripheral blood progenitorcells In myeloid reconstitution after autologous or allogeneic bone marrow transplantation In bone marrow transplantation failure or engraftment delay In neutropenia induced by chemotherapyPart 2 – Injections: Drugs S-Z Policy

inject drug s-z2Page updated: September 2020DosageThe recommended dose varies according to the condition being treated. Please see theappropriate medical literature for details.Required CodesOne of the following ICD-10-CM diagnosis codes is required for llingHCPCS code J2820 (injection, sargramostim [GM-CSF], 50 mcg).Sebelipase AlfaSebelipase alfa is a hydrolytic lysosomal cholsteryl ester and triacylglycerol-specific enzymeindicated for the treatment of patients with a diagnosis of lysosomal acid lipase deficiency(LAL-D).DosagePatients with rapidly progressive LAL-D presenting within the first six months of lifeThe recommended dosage is 1 mg/kg as an intravenous infusion once per week. Forpatients who do not achieve an optimal clinical response, increase to 3 mg/kg once perweek.Pediatric and adult patients with LAL-DThe recommended dosage is 1 mg/kg as an intravenous infusion once every other week.Part 2 – Injections: Drugs S-Z Policy

inject drug s-z3Page updated: September 2020Required CodeICD-10-CM diagnosis code E77.0BillingHCPCS code J2840 (injection, sebelipase alfa, 1 mg)SecretinSecretin is indicated for use in secretin stimulation testing to: Aid in the diagnosis of pancreatic exocrine dysfunction Aid in the diagnosis of gastrinoma Facilitate the identification of the ampulla of Vater and accessory papilla duringendoscopic retrograde cholangiopancreatography.DosageThe maximum allowable dosage is 48 mcg.BillingHCPCS code J2850 (injection, secretin, synthetic, human, 1 mcg).SiltuximabSiltuximab is a human-mouse chimeric monoclonal antibody that binds humaninterleukin-6 (IL-6) and prevents the binding of IL-6 to both soluble and membrane-bound IL6 receptors. IL-6 has been shown to be involved in diverse normal physiologic processessuch as induction of immunoglobulin secretion. Over production of IL-6 has been linked tosystemic manifestations in patients with multicentric Castleman’s disease (MCD).IndicationsFor the treatment of patients 18 years of age or older with MCD who are humanimmunodeficiency virus negative and human herpesvirus-8 negative.Part 2 – Injections: Drugs S-Z Policy

inject drug s-z4Page updated: September 2020AuthorizationAn approved Treatment Authorization Request (TAR) is required for reimbursement.DosageThe recommended dose is 11mg/kg intravenously every three weeks until treatment failure.BillingHCPCS code J2860 (injection, siltuximab, 10 mg).Sodium Ferric Gluconate Complex in SucroseSodium ferric gluconate complex in sucrose, 12.5 mg injection (HCPCS code J2916) isreimbursable when used to treat patients with iron deficiency anemia and for patientsundergoing long term hemodialysis and who are also receiving supplemental erythropoietin(EPO) therapy. Sodium ferric gluconate complex may be used as an alternative to oral irontherapy.DosageThe recommended dosage is 10 ml (125 mg of elemental iron) administered intravenouslyduring the dialysis session. Patients may continue to require therapy with sodium ferricgluconate complex in sucrose at the lowest dose necessary to maintain target levels ofhemoglobin.The maximum dosage is 125 mg per day.Part 2 – Injections: Drugs S-Z Policy

inject drug s-z5Page updated: September 2020Somatropin for HIV-Associated WastingSomatropin is used for the treatment of HIV-associated wasting and is reimbursable onlywith an approved TAR. A TAR will be granted in four-week intervals to a maximum of 12continuous weeks of therapy. Treatment must be reevaluated after four weeks and eightweeks of therapy.Initial Therapy: CriteriaCriteria for the initial 28 days of treatment of HIV-associated wasting with somatropin: Documentation in the medical record of complete history and physical examinationincluding:– History of nutritional status including appetite, estimation of caloric intake,gastrointestinal function including presence of diarrhea and number of daily stools,and history of endoscopic procedures– Psychosocial evaluation, including presence of significant anxiety and/or depressionaffecting food intake Record of the following measurements:– Height, weight, ideal body weight, body mass index (BMI)– Body cell mass (BCM) by bioelectrical impedance analysis (BIA)– Serial measurements – weekly Patients must meet one of the following criteria for HIV-associated wasting:– 5 percent BCM loss within the preceding six months– In men: BCM less than 35 percent of total body weight and BMI less than 27 kg/m2– In women: BCM less than 23 percent of total body weight and BMI less than27 kg/m2– BMI less than 20 kg/m2– BMI greater than 20 kg/m2 and less than 25 kg/m2 and 10 percent unintentional weight loss within the preceding 12 months or 7.5 percent unintentional weight loss within the preceding six monthsPart 2 – Injections: Drugs S-Z Policy

inject drug s-z6Page updated: September 2020 Patients should have an evaluation of gastrointestinal function with attention to thepresence of malabsorption, a review of food intake, amount of daily calories andestimate of physical activity level. An active malignancy other than Kaposi’s sarcoma has been excluded clinically,through diagnostic laboratory examination, and/or radiographically. Male patients should have a serum testosterone level and, if low, a trial of testosteronereplacement therapy. Patients must have a viral load assay and a CD4 count and must be undergoingtreatment with an appropriate antiretroviral therapy regimen. Patients should have a trial with an appetite stimulant if they have inadequate caloricintake and anorexia. For male patients, an initial trial of androgen is recommended for HIV-associatedwasting. If this is omitted, a statement should be provided documenting the clinicaldecision to proceed directly with somatropin therapy. Patients must receive somatropin within recommended dosing guidelines for bodyweight.Reassessment of Therapy Through 12 Weeks: CriteriaCriteria for reassessment of therapy through 12 weeks: Treatment must be re-evaluated after four weeks and eight weeks of therapy. Repeatweight assessment and documentation is required at four weeks and eight weeks oftherapy to assure weight stabilization. Therapy must be discontinued in patients who continue to lose weight in the first fourweeks of treatment. If, after four weeks of therapy, weight loss has stopped or if the patient is gainingweight, somatropin may be continued for another 28 days. If, after eight weeks of therapy, the patient is losing or has failed to gain weight fromthe original measurement, somatropin must be stopped. If the patient had initially gained weight at four weeks, but has neither gained nor lostweight at the eight-week re-evaluation, somatropin may be continued for another 28days.Part 2 – Injections: Drugs S-Z Policy

inject drug s-z7Page updated: September 2020 A maximum of 12 weeks of treatment is allowed with authorization. Claims withoutauthorization will be denied.Note: Authorization is limited to four-week intervals.Continued Therapy Beyond 12 Weeks: CriteriaCriteria for continued therapy beyond the initial 12 weeks: All patients must stop somatropin following the initial 12-week treatment for aneight-week period of observation unless there is documentation that HIV-associatedwasting is still present. During the eight-week observation period, body weight, BMIand BCM should be monitored on a weekly basis. Therapy beyond 12 weeks may be continued with a patient who has demonstrated abeneficial response to somatropin during the initial 12 weeks of therapy (defined as atwo percent or greater increase in body weight or BCM) and– Still exhibits evidence of wasting (BMI less than 20 kg/m2) or– Has a BCM not yet normalized (BCM less than 40 percent in non-obese men or lessthan 28 percent in non-obese women). As long as the patient continues to gain weight or BCM, somatropin may be extendedevery 28 days, with authorization, until BCM and/or weight are normalized. Once BCM and/or weight have normalized, somatropin should be stopped.Reinitiating Somatropin Therapy Within Six Months: CriteriaCriteria for reinitiating somatropin therapy within six months: Patients may resume somatropin therapy within six months of initial therapy if there isdocumentation of an unintentional five percent loss of body weight or BCM loss ofgreater than five percent or any of the criteria for HIV-associated wasting within sixmonths after completion of an uninterrupted 12-week course of somatropin therapy. Reinitiating somatropin is allowed for up to an additional 12 weeks, withreassessments required at the same four and eight week intervals during the second12-week course of therapy. A recent copy of the patient’s BIA documenting the BCMloss is required with TAR submission.Part 2 – Injections: Drugs S-Z Policy

inject drug s-z8Page updated: September 2020Repeat Somatropin Therapy After Cessation: CriteriaCriteria for repeat somatropin therapy six months after cessation of treatment: If the patient has not re-initiated somatropin six months after completing anuninterrupted 12-week course of therapy, somatropin may be repeated, provided thecriteria for initial 28 days of therapy are met. Reinitiating somatropin is allowed for upto an additional 12 weeks, with reassessments required at the samefour- and eight-week intervals during the second 12-week course of therapy. A recentcopy of the patient’s BIA is required with TAR submission. Trials of alternate treatment may be omitted if previous use in the patient wasunsuccessful. The use of somatropin beyond the initial 12-week course must meet thecriteria stated above for continued treatment.SotalolSotalol has both beta-adrenoreceptor blocking (Vaughan Williams Class II) and cardiacaction potential duration prolongation (Vaughan Williams Class III) antiarrhythmicproperties. Intravenous sotalol hydrochloride is a racemic mixture of d- and l-sotalol. Bothisomers have similar Class III antiarrhythmic effects, while the l-isomer is responsible forvirtually all of the beta-blocking activity.IndicationsSotalol is indicated for the maintenance of normal sinus rhythm (delay in time to recurrenceof atrial fibrillation/atrial flutter [AFIB/AFL]) in patients with symptomatic AFIB/AFL who arecurrently in sinus rhythm. Because sotalol can cause life-threatening ventriculararrhythmias, it should be reserved for patients in whom AFIB/AFL is highly symptomatic.Sotalol is indicated for patients 18 years of age and older.AuthorizationA Treatment Authorization Request (TAR) is required for reimbursement.Part 2 – Injections: Drugs S-Z Policy

inject drug s-z9Page updated: September 2020Required CodesSotalol is reimbursable only when billed in conjunction with one of the following ICD-10-CMdiagnosis codes:I48.0 thru I48.4I48.91I48.92DosageStarting adult dose is 75 mg administered twice daily. If creatinine clearance is between 60and 40 mL/min, administer once daily, if less than 40 mg/mL, sotalol is not recommended.BillingHCPCS code C9482 (injection, sotalol hydrochloride, 1 mg)Taliglucerase AlfaTaliglucerase alfa, a hydrolytic lysosomal glucocerebroside-specific enzyme for intravenousinfusion, is a recombinant active form of the lysosomal enzyme, β-glucocerebrosidase,which is expressed in genetically modified carrot plant root cells cultured in a disposablebioreactor system. Β-glucocerebrosidase is a lysosomal glycoprotein enzyme that catalyzesthe hydrolysis of the glycolipid glucocerebroside to glucose and ceramide.IndicationsFor use for adults with confirmed diagnosis of Type 1 Gaucher disease.AuthorizationThe Treatment Authorization Request (TAR) must include a diagnosis of Type 1 Gaucherdisease. For other TAR requirements, refer to the “Enzyme Replacement Drugs” topic in theInjections: Drugs E-H Policy section in this manual.Part 2 – Injections: Drugs S-Z Policy

inject drug s-z10Page updated: September 2020DosageThe recommended dose is 60 units/kg of body weight administered once every two weeksas a 60 - 120 minute intravenous infusion. The maximum dose is 8,160 mg per day.BillingHCPCS code J3060 (injection, taliglucerase alfa, 10 units).Tbo-FilgrastimTbo-filgrastim is a non-glycosylated recombinant methionyl human granulocytecolony-stimulating growth factor (r-metHuG-CSF) manufactured by recombinant DNAtechnology using the bacterium strain E. coli K802. It binds to G-CSF receptors andstimulates proliferation neutrophils. G-CSF is known to stimulate differentiation commitmentand some end-cell functional activation, which increases neutrophil counts and activity.IndicationsTo reduce the duration of severe neutropenia in adult patients (18 years of age and older)with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associatedwith a clinically significant incidence of febrile neutropenia.DosageThe recommended dose of tbo-filgrastim is 5 mcg/kg per day administered as asubcutaneous injection. Administer the first dose of tbo-filgrastim no earlier than 24 hoursfollowing myelosuppressive chemotherapy.Required CodesTbo-filgrastim is reimbursable when billed with one of the following ICD-10-CM diagnosiscodes:D70.1Z51.11D70.2Z51.89BillingHCPCS code J1447 (injection, tbo-filgrastim, 1 microgram).Part 2 – Injections: Drugs S-Z Policy

inject drug s-z11Page updated: January 2021Tedizolid PhosphateTedizolid phosphate, 1 mg injection (HCPCS code J3090) is restricted to patients 18 yearsof age and older.‹‹Teprotumumab-trbwTeprotumumab's mechanism of action in patients with thyroid eye disease has not been fullycharacterized. Teprotumumab binds to insulin-like growth factor-1 receptor inhibitor andblocks its activation and signaling.IndicationsAll FDA-approved indications.DosageFDA-approved dosages.TAR RequirementAn approved Treatment Authorization Request (TAR) is required for reimbursement.TAR CriteriaTeprotumumab-trbw will be considered medically necessary when all of the following criteriaare met: Must be prescribed for FDA-approved indications and dosages Patient must be 18 years of age or older Patient must have a clinical diagnosis of Grave’s disease associated with active thyroideye disease (TED) with a clinical activity score (CAS) of greater than or equal to 4 forthe most severely affected eye Patient must be less than 9 months from the onset of TED symptoms Patient must be euthyroid or with mild hypo- or hyperthyroidism defined as freethyroxine and free triiodothyronine levels less than 50% above or below the normallimits Must be prescribed by or in consultation with an ophthalmologist, endocrinologist or aphysician who specializes in treatment of thyroid eye disease Patient does not require surgical ophthalmological intervention››Part 2 – Injections: Drugs S-Z Policy

inject drug s-z12Page updated: January 2021 ‹‹Patient must not have poorly controlled diabetes Patient has a contraindication, intolerance, or lack of response to glucocorticoidsAuthorization is for 6 months (a maximum of 8 infusions).Continued Therapy Patient continues to meet initial coverage criteria Patient is responding positively to therapy as evidenced by a greater than or equal to 2point reduction in CAS from baseline and a greater than or equal to 2 mm reduction inproptosis from baseline Patient continues to have active TED with a CAS of greater than or equal to 3Reauthorization is for 6 months (a maximum of 8 infusions).Age LimitsMust be 18 years of age or olderBillingHCPCS code J3241 (Injection, teprotumumab-trbw, 10 mg)Suggested ICD-10-CM Diagnosis CodesE05.00Prescribing RestrictionsFrequency of billing 10 mg/kg initial dose, then 20 mg/kg every 3 weeks for 7 additionaldoses››Part 2 – Injections: Drugs S-Z Policy

inject drug s-z13Page updated: January 2021Thyrotropin AlfaThyrotropin alfa is reimbursable for use in the following groups: (1) as a diagnostic tool forserum thyroglobulin testing with or without radioiodine imaging in the follow-up of patientswith well-differentiated thyroid cancer and (2) as an adjunctive treatment for radioiodineablation of thyroid tissue remnants in patients who have undergone a near-total or totalthyroidectomy for well-differentiated thyroid cancer and who do not have evidence ofmetastatic thyroid cancer.DosageA two-injection regimen is recommended. The two-injection regimen is thyrotropin alfa0.9 mg intramuscularly (IM) followed by a second 0.9 mg IM injection 24 hours later.For imaging or remnant ablation, radioiodine administration should be given 24 hoursfollowing the final thyrotropin alfa injection.A post-ablation scan should be performed three to five days after radioiodine administration.A diagnostic serum thyroglobulin with or without scanning should be performed 48 hoursafter radioiodine administration.AuthorizationAn approved Treatment Authorization Request (TAR) is required for reimbursement.BillingHCPCS code J3240 (injection, thyrotropin alpha, 0.9 mg) provided in 1.1 mg vial.Part 2 – Injections: Drugs S-Z Policy

inject drug s-z14Page updated: January 2021TigecyclineTigecycline, 1 mg (HCPCS code J3243) has a maximum daily dosage of 100 mg.Safety warning: All-cause mortality was higher in patients treated with tigecycline thancomparators in a meta-analysis of clinical trials. Tigecycline should bereserved for use in situations when alternative treatments are not suitable.Tildrakizumab-asmnTildrakizumab-asmn is an interleukin-23 antagonist in solution for subcutaneous (SQ) use.IndicationsTildrakizumab-asmn is used to treat patients with moderate-to-severe chronic plaquepsoriasis (i.e. extensive and/or disabling disease) who are candidates for phototherapy orsystemic therapy and when other systemic therapies are medically less appropriate.Age18 years and olderDosage100 mg SQ injection administered at weeks 0 and 4, and every 12 weeks thereafter.AuthorizationAn approved Treatment Authorization Request (TAR) is required for reimbursement.The TAR must include clinical documentation that demonstrates all of the following: The service is medically necessary to treat moderate-to-severe chronic plaquepsoriasis who are candidates for systemic or phototherapy and when other systemictherapies are medically less appropriate. Alternative psoriasis therapies (e.g. phototherapy, oral agents, etc.) have been tried orconsidered, have failed, or arecontra-indicated. The physician’s legible, complete, and signed treatment plan/order fortildrakizumab-asmn.Part 2 – Injections: Drugs S-Z Policy

inject drug s-z15Page updated: January 2021BillingHCPCS code J3245 (injection, tildrakizumab-asmn, 1 mg)One (1) unit of J3245 1 mg of tildrakizumab-asmn solutionTocilizumabTocilizumab is an interleukin-6 (IL-6) receptor antagonist for intravenous (IV) orsubcutaneous (SQ) administration.IndicationsTocilizumab is used to treat the following conditions: Rheumatoid Arthritis Giant Cell Arteritis Polyarticular Juvenile Idiopathic Arthritis Systemic Juvenile Idiopathic Arthritis Cytokine Release SyndromeAge2 years and olderDosageThe recommended dosage varies based on the patient’s treatment condition, age, laboratorymeasurements, and response to therapy.Part 2 – Injections: Drugs S-Z Policy

inject drug s-z16Page updated: January 2021AuthorizationAn approved Treatment Authorization Request (TAR) is required for reimbursement.The TAR should include clinical documentation that demonstrates the following: The service is medically necessary. Alternative treatments have been tried or considered, have failed, or arecontraindicated. The physician’s legible, complete, and signed treatment plan/order for tocilizumab.BillingHCPCS code J3262 (injection, tocilizumab, 1 mg)One (1) unit 1 mg of tocilizumabTreprostinilTreprostinil, 1 mg, (HCPCS code J3285) is reimbursable for patients 16 years of age orolder with pulmonary hypertension. Claims require authorization.Triamcinolone Acetonide Extended-Release InjectableSuspension (Zilretta)Triamcinolone acetonide extended-release injectable suspension is a microsphereformulation of triamcinolone acetonide, a corticosteroid, to be administered by intra-articularinjection.IndicationsAll FDA-approved indications.DosageFDA-approved dosages.Part 2 – Injections: Drugs S-Z Policy

inject drug s-z17Page updated: January 2021AuthorizationAn approved Treatment Authorization Request (TAR) is required for reimbursement.Triamcinolone acetonide extended-release injection is considered medically necessary whenthe following criteria are met: For FDA-approved indications and dosages Patient must be 18 years of age or older Patients must have a diagnosis of osteoarthritis of the knee; and Patient must have inadequate response, intolerance or contraindication to at least twoof the following:– Acetaminophen– Oral NSAIDs– Topical NSAIDs; and Patient must have treatment failure, intolerance or contraindication to short-acting,intra-articular steroid injections or adequate pain control but with drug-inducedhyperglycemia Approval will be granted for a maximum of one dose (32 mg) of triamcinoloneacetonide extended-release injection per knee per lifetimeOne approval will be granted for a duration of six months. The TAR is not renewable.Age LimitsMust be 18 years of age or olderBillingHCPCS code J3304 (injection, triamcinolone acetonide, preservative-free, extended-release,microsphere formulation, 1 mg)Must use modifiers RT, LT for applicable knee(s).Part 2 – Injections: Drugs S-Z Policy

inject drug s-z18Page updated: January 2021Prescribing RestrictionsFrequency of billing no repeat administrationMaximum billing unit(s) 32 mg 32 units each kneeTriptorelin XRTriptorelin extended-release (XR) is a gonadotropin-releasing hormone (GnRH) forintramuscular (IM) administration.IndicationsTriptorelin XR is used for the treatment of pediatric patients with central precocious puberty.Age2 to 12 years of ageDosageThe recommended dose is 22.5 mg IM injection given once every 24 weeks.AuthorizationAn approved Treatment Authorization Request (TAR) is required for reimbursement.The TAR should include clinical documentation that demonstrates all of the following: A diagnosis of central precocious puberty (idiopathic or neurogenic) as defined by theonset of secondary sexual characteristics before the age of 8 years in girls and age 9years in boys. The clinical diagnosis is confirmed by a pubertal basal level of luteinizing hormone(LH) based on the laboratory reference ranges, a pubertal response to a GnRHstimulation test, and the child’s bone age is advanced one year or more beyond thechild’s chronologic age.Part 2 – Injections: Drugs S-Z Policy

inject drug s-z19Page updated: January 2021 Alternate etiologies of precocious puberty have been considered, evaluated, andruled-out by baseline evaluation and testing such as height, weight, and heightvelocity; a brain MRI; gonadal and adrenal ultrasound imaging; serum levels ofestrogen or testosterone; and adrenal steroids and beta human chorionic gonadotropinlevels.Required CodesThe following ICD-10-CM diagnosis code is required for reimbursement: E22.8 (Other hyperfunction of pituitary gland [central precocious puberty])BillingHCPCS code J3316 (injection, triptorelin extended-release, 3.75 mg)One (1) unit of J3316 3.75 mg triptorelin extended-release injection solutionUstekinumabUstekinumab is a human IgG1қ monoclonal antibody that binds with high affinity andspecificity to the p40 protein subunit used by both the interleukin (IL)-12 and IL-23 cytokines.IL-12 and IL-23 are naturally occurring cytokines that are involved in inflammatory andimmune responses, such as natural killer cell activation and CD4 T-cell differentiation andactivation. Ustekinumab disrupts IL-12 and IL-23 mediated signaling and cytokinecascades.IndicationsFor the treatment of adult patients 18 years of age and older with moderate to severe plaquepsoriasis who are candidates for phototherapy or systemic therapy.Required CodesRestricted to ICD-10-CM diagnosis code L40.0.Part 2 – Injections: Drugs S-Z Policy

inject drug s-z20Page updated: January 2021DosageUstekinumab is administered by subcutaneous injection.For patients weighing 100 kg, the recommended dose is 45 mg initially and four weekslater, followed by 45 mg every 12 weeks.For patients weighing 100 kg, the recommended dose is 90 mg initially and four weekslater, followed by 90 mg every 12 weeks.BillingHCPCS code J3357 (ustekinumab, for subcutaneous injection, 1 mg)Ustekinumab IntravenousUstekinumab is a human IgG1қ monoclonal antibody that binds with specificity to the sharedp40 protein subunit used by both the IL-12 and IL-23 cytokines. In the pathophysiology ofpsoriatic inflammatory diseases IL-12 and IL-23 are naturally occurring cytokines that areinvolved in inflammatory and immune responses, such as natural killer cell activation andCD4 T-cell differentiation and activation. Levels of IL-12/23 and p40 are elevated in theskin and blood of psoriasis patients, and blood of psoriatic arthritis patients. Ustekinumabdisrupts IL-12 and IL-23 mediated signaling and cytokine cascades. The cytokines IL-12and IL-23 have been implicated as important contributors to the chronic inflammation thatoccurs in Crohn’s disease.IndicationsUstekinumab intravenous (I.V.) is indicated for the treatment of adult patients age 18 yearsof age and older with: Moderate to severe plaque psoriasis who are candidates for phototherapy or systemictherapy. Active psoriatic arthritis, alone or in combination with methotrexate. Moderately to severely active Crohn’s disease (CD) who have failed or were intolerantto:– Treatment with immunomodulators or corticosteroids, but never failed a tumornecrosis factor (TNF) blocker, or– Treatment with one or more TNF blockers.Part 2 – Injections: Drugs S-Z Policy

inject drug s-z21Page updated: January 2021DosageAdminister Ustekinumab I.V. according to the following conditions:Moderate to Severe Plaque Psoriasis: For patients weighing 100 kg (220 lbs), the recommended dose is 45 mg initially andfour weeks later, followed by 45 mg every 12 weeks. For patients weighing 100 kg (220 lbs), the recommended dose is 90 mg initially andfour weeks later, followed by 90 mg every 12 weeks.Active Psoriatic Arthritis: The recommended dose is 45 mg initially and four weeks later, followed by 45 mgevery 12 weeks. For patients with co-existent moderate-to-severe plaque psoriasis weighing 100 kg(220 lbs), the recommended dose is 90 mg initially and four weeks later, followed by90 mg every 12 weeks.Moderately to Severely Active Crohn’s Disease:Intravenous induction adult dosage regimen:A single intravenous infusion using weight-based dosing. 55 kg or less: 260 mg More than 55 kg, up to exactly 85 kg: 390 mg More than 85 kg: 520 mg The recommended maintenance dosage is a subcutaneous 90 mg dose administeredeight weeks after the initial intravenous dose, then every eight weeks thereafter.AuthorizationAn approved TAR is required for reimbursement. The TAR must document that the patienthas moderate to severe plaque psoriasis, active psoriatic arthritis or Crohn’s disease.Part 2 – Injections: Drugs S-Z Policy

inject drug s-z22Page updated: January 2021BillingHCPCS code J3358 (ustekinumab, for intravenous injection, 1 mg)VancomycinVancomycin is a glycopeptide antibiotic that is reimbursable when used for the treatment ofserious or severe infections caused by susceptible strains of gram positive bacteria.DosageThe initial intravenous dose should be based on actual body weight, with subsequent dosingbased on serum trough vancomycin concentrations.BillingHCPCS code J3370 (injection, vancomycin HCl, 500 mg)One (1) unit 500 mgVedolizumabVedolizumab is a humanized IgG1 monoclonal antibody produced in Chinese hamster ovarycells that binds to the human α4β7 integrin and blocks the interaction of α4β7 integrin withmucosal addressin cell adhesion molecule-1 (MAdCAM-1) and inhibits migration of memoryT-lymphocytes across the endothelium into inflamed gastrointestinal parenchymal tissue.The interaction of the α4β7 integrin with MAdCAM-1 has been implicated as an importantcontributor to the chronic inflammation that is a hallmark of ulcerative colitis (UC) andCrohn’s disease (CD).IndicationsUlcerative Colitis:Adult patients 18 years of age and older with moderately to severely active UC who havehad an inadequate response with, lost response to or were intolerant to a tumor necrosisfactor (TNF) blocker or immunomodulator; or had an inadequate response with, wereintoler

inject drug s-z 4 Part 2 – Injections: Drugs S-Z Policy Page updated: September 2020 Authorization An approved Treatment Authorization Request (TAR) is required for reimbursement. Dosage The recommended dose is 11mg/kg

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